Phase 4
N=69
Long-Term Growth and Skeletal Effects of Early Growth Hormone Treatment in Turner Syndrome
Turner Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00266656 ↗Enrolled (actual)
69
Serious AEs
15.9%
Results posted
Aug 2016
Primary outcome: Primary: Most Mature Height Standard Deviation Score (SDS) — -1.37; -1.60 standard deviation score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Humatrope (Drug)
- Age
- Pediatric, Adult · 4+ yrs
- Sex
- Female
- Sponsor
- Eli Lilly and Company
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Most Mature Height Standard Deviation Score (SDS) |
-1.37; -1.60 | — |
| SECONDARY Height SDS at Various Ages |
-0.66; -1.28; -1.29; -1.87; -1.66; -1.69 | — |
| SECONDARY Age at Attainment of Tanner 2 Breast Development |
11.80; 12.14 | — |
| SECONDARY Chronological Age at First Visit Participant Attained Bone Age of 14.5 Years |
14.64; 15.26 | — |
| SECONDARY Reports of Serious Adverse Events |
8; 5 | — |
| SECONDARY Percentage of Participants With Occurrence of Pre-specified Clinically Relevant Events |
13.9; 18.2; 0; 3.0; 13.9; 6.1 | — |
| SECONDARY Percentage of Participants With Abnormal Tympanometry Results |
44.4; 54.5; 47.2; 45.5; 27.8; 15.2 | — |
| SECONDARY Percentage of Participants With Prevalence of Abnormal Audiometry Results |
52.8; 48.5; 44.4; 29.2; 85.7; 66.7 | — |
| SECONDARY Percentage of Participants With Abnormal Audiometry Results Based on Pure Tone Average (PTA) |
30.6; 31.3; 2.8; 0.0; 22.2; 37.5 | — |
Summary
This is an extension study that will gather long-term data on the effect of early growth hormone (GH) treatment on adult height and other aspects of health and development in girls with Turner syndrome. The main purpose is to determine whether girls who received 2 years of GH treatment before 6 years of age achieve taller adult height than girls who were untreated during this time. The study will also look at middle ear and hearing function, and cognitive and behavioral development. Protocol completion is defined as attainment of height velocity less than or equal to 1.0 cm/year, or bone age greater than or equal to 15 years.
Eligibility Criteria
Inclusion Criteria
- Previously randomized in study B9R-US-GDFG (NCT00406926)
- Karyotype-proven Turner syndrome
Exclusion Criteria
- Immediate family members of study site personnel directly affiliated with the study
Data sourced from ClinicalTrials.gov (NCT00266656). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.